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联邦制药:TUL01101片已完成中重度特应性皮炎成人受试者中的II期临床研究
Zhi Tong Cai Jing· 2025-11-10 14:59
Core Viewpoint - The company has successfully completed Phase II clinical trials for its innovative drug TUL01101, demonstrating significant efficacy and safety in treating moderate to severe atopic dermatitis in adults [1][2]. Group 1: Clinical Trial Details - The Phase II study was a multicenter, randomized, double-blind, parallel, placebo-controlled trial involving 201 adult participants with moderate to severe atopic dermatitis [1]. - Participants were randomly assigned to three different dosage groups (20mg, 40mg, 60mg) and a placebo group, receiving daily doses for 12 weeks [1]. - The primary efficacy endpoint was the change in the Eczema Area and Severity Index (EASI) score from baseline at week 12, with key secondary endpoints including the proportion of participants achieving EASI75 response and Investigator's Global Assessment (IGA) response [1]. Group 2: Trial Results - Results indicated that TUL01101 significantly improved skin lesions, reduced itching, and enhanced quality of life, with notable decreases in EASI scores observed as early as week 1 [2]. - By week 12, the EASI score changes from baseline for the 20mg, 40mg, and 60mg groups were -81.98%, -79.87%, and -87.85% respectively, with EASI75 response rates of 78.0%, 80.0%, and 84.0%, and IGA response rates of 46.0%, 52.0%, and 68.0% [2]. - The overall safety profile of TUL01101 was good, with the most common adverse event being upper respiratory tract infection, primarily mild to moderate in severity, and no new safety signals were identified [2]. Group 3: Future Development - TUL01101 is a highly selective JAK1 inhibitor, currently approved for clinical trials in atopic dermatitis and rheumatoid arthritis in China [3]. - The company plans to continue expanding clinical research for TUL01101 in the field of autoimmune diseases [3].
联邦制药(03933) - 本集团產品TUL01101片临床研究进展
2025-11-10 14:51
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對 其準確性或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份 內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 (於開曼群島成立之有限公司) (股份代號: 3933) 本集團產品 TUL01101 片臨床研究進展 本公告乃由聯邦制藥國際控股有限公司(「本公司」)自願發出。 本公司董事會(「董事會」)欣然公佈,本公司全資附屬公司珠海聯邦制藥股份有限 公司自主研發的 1 類創新藥 TUL01101 片已完成在中國中重度特應性皮炎成人受試者 中的 II 期臨床研究。 承董事會命 聯邦制藥國際控股有限公司 主席 蔡海山 香港,二零二五年十一月十日 本研究採用多中心、隨機、雙盲、平行、安慰劑對照設計,共納入 201 例受試者,隨 機分配至 TUL01101 片三個不同劑量組(20 mg、40 mg、60 mg)及安慰劑組中,每 日給藥一次連續給藥 12 周,旨在評估 TUL01101 片在 ...
医药生物行业跟踪周报:特色原料药触底积极变化,重点推荐奥锐特、普洛药业等-20251109
Soochow Securities· 2025-11-09 10:00
Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [1]. Core Views - The report highlights a positive change in the specialty raw materials sector, recommending companies such as Aorite and Prolo Pharmaceuticals [1]. - The report suggests that the Q3 performance of raw material pharmaceutical companies has reached a bottom, indicating potential recovery in profitability as high-cost inventory is consumed [19][20]. Summary by Sections Investment Highlights - The recommended sub-industry rankings are: Innovative Drugs > Research Services > CXO > Traditional Chinese Medicine > Medical Devices > Pharmacies [3][12]. - Specific stock recommendations include: - From raw materials: Aorite, Qianhong Pharmaceutical - From Traditional Chinese Medicine: Zorui Pharmaceutical, Fangsheng Pharmaceutical, Dong'e Ejiao - From medical devices: United Imaging Healthcare, Yuyue Medical - From AI pharmaceuticals: Jingtai Holdings - From GLP-1 sector: Lianbang Pharmaceutical, Borui Pharmaceutical, Zhongsheng Pharmaceutical, and Innovent Biologics - From PD-1/VEGF dual antibodies: Sanofi Biopharmaceuticals, Kangfang Biologics, and Rongchang Biopharmaceuticals - From innovative drugs: Innovent Biologics, BeiGene, HengRui Medicine, Zai Lab, Baillie Tianheng, Kelun Pharmaceutical, Dize Pharmaceutical, and Haizheng Pharmaceutical [3][15]. Industry Trends - The A-share pharmaceutical index has seen a year-to-date increase of 18.2%, while the Hang Seng Biotechnology Index has increased by 76.6% [6][11]. - The report notes that the raw material pharmaceutical sector is under pressure due to high base effects and declining prices, with significant revenue impacts [19][20]. R&D Progress and Company Dynamics - Recent approvals include Novartis' radioligand therapy drug, which received dual indications for prostate cancer treatment [2]. - The report provides an overview of ongoing clinical trials and drug approvals, emphasizing the importance of innovation in the pharmaceutical sector [30]. Market Performance - The report indicates that the pharmaceutical sector has experienced adjustments, with notable stock performances including significant gains for companies like Hezhong China (+61%) and Wanze Shares (+30%) [11]. - The report also highlights the performance of various pharmaceutical stocks, noting both gains and losses in the market [16][17]. Raw Material Pricing Trends - The price of 6-APA has dropped significantly, from 370 RMB/kg in 2022 to 180 RMB/kg in October 2025, a decrease of 51% [23]. - The price of Amoxicillin has also decreased from 320 RMB/kg in January 2023 to 190 RMB/kg in October 2025, a decline of 41% [23]. Conclusion - The report suggests that as high-cost inventory is depleted, the gross margins for raw material producers are expected to improve, indicating a potential recovery in profitability for companies like Fuxiang Pharmaceutical and Lukang Pharmaceutical [19][23].
联邦制药(03933):受托人购入350万股奖励股份
智通财经网· 2025-11-05 10:51
Core Viewpoint - Federal Pharmaceutical (03933) announced the purchase of 3.5 million shares of reward stock at an average price of HKD 12.905 per share, to fulfill its obligation to the beneficiaries who have met the 2024 performance targets by November 13, 2025 [1] Group 1 - The trustee has acquired the shares through market transactions [1] - The trustee will continue to purchase the relevant number of reward shares depending on market conditions [1] - The reward shares will be held in trust until they vest and are delivered to the beneficiaries according to the terms of the share award plan [1]
联邦制药:受托人购入350万股奖励股份
Zhi Tong Cai Jing· 2025-11-05 10:49
Core Viewpoint - The company announced the purchase of 3.5 million shares at an average price of HKD 12.905 per share to fulfill its obligations under the share award plan for achieving 2024 performance targets [1] Group 1 - The trustee has acquired 3.5 million shares through market transactions [1] - The average purchase price per share was HKD 12.905 [1] - The shares will be held in trust until they vest to the relevant award recipients according to the terms of the share award plan [1] Group 2 - The trustee will continue to purchase additional shares depending on market conditions [1] - The shares are intended for individuals who have met the performance targets set for 2024 [1]
联邦制药(03933.HK):受托人透过市场交易购入350万股奖励股份
Ge Long Hui· 2025-11-05 10:47
Core Viewpoint - The company, 联邦制药 (03933.HK), announced the purchase of 3.5 million reward shares at an average price of HKD 12.905 per share to fulfill its obligation to the beneficiaries who met the 2024 performance targets by November 13, 2025 [1] Group 1 - The trustee has acquired 3.5 million reward shares through market transactions [1] - The average purchase price for the shares was HKD 12.905 each [1] - The trustee will continue to purchase additional reward shares depending on market conditions until the shares are vested to the beneficiaries [1]
联邦制药(03933) - 自愿公告购入奖励股份
2025-11-05 10:37
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對 其準確性或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份 內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 茲提述本公司日期為二零二三年十一月十三日的公告(「該公告」),內容有關根據二零 二三年股份獎勵計劃(「股份獎勵計劃」)的條款向承授人授出合共12,096,900股獎勵股 份。除文義另有界定外,本公告所用詞彙與該公告所賦予者具有相同涵義。 於二零二五年十月,受託人已透過市場交易購入3,500,000股獎勵股份,每股平均價格為 港幣12.905元,以履行於二零二五年十一月十三日對已完成二零二四年績效目標的承受 人的歸屬義務。 受託人將視乎市況繼續於市場購買相關數目的獎勵股份,並以信託形式為相關承授人 持有有關獎勵股份,直至獎勵股份根據股份獎勵計劃的條款歸屬予有關承授人並交收 為止。 承董事會命 聯邦制藥國際控股有限公司 主席 蔡海山 香港,二零二五年十一月五日 於本公告日期,董事會成員包括:執行董事蔡海山先生、梁永康先生、蔡紹哲女士、 方煜平先生、鄒鮮紅女士及朱蘇燕女士;以及獨立非執行董事張品文先生、宋敏教 ...
联邦制药(03933) - 截至2025年10月31日止月份之股份发行人的证券变动月报表
2025-11-05 04:22
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 聯邦制藥國際控股有限公司 呈交日期: 2025年11月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 03933 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 3,800,000,000 | HKD | | 0.01 | HKD | | 38,000,000 | | 增加 / 減少 (-) | | | | | | | HKD | | | | 本月底結存 | | | 3,800,000,000 | HKD | | 0.01 | HKD | | 38,000,000 | 本月底法定/ ...
智通港股通资金流向统计(T+2)|11月3日
智通财经网· 2025-11-02 23:32
Core Insights - The article highlights the net inflow and outflow of funds for various companies in the Hong Kong stock market, indicating significant movements in investor sentiment and market dynamics [1][2][3] Net Inflow Summary - The top three companies with the highest net inflow of funds are Huahong Semiconductor (华虹半导体) with 388 million, Pop Mart (泡泡玛特) with 320 million, and Qingdao Beer (青岛啤酒股份) with 305 million [1][2] - The net inflow percentages for these companies are 8.15%, 7.92%, and 58.54% respectively, indicating strong investor interest, particularly in Qingdao Beer [2][3] Net Outflow Summary - The companies with the highest net outflow of funds include Alibaba-W (阿里巴巴-W) with -523 million, Southern Hang Seng Technology (南方恒生科技) with -429 million, and Tencent Holdings (腾讯控股) with -355 million [1][2] - The net outflow percentages for these companies are -3.89%, -4.86%, and -3.36% respectively, reflecting a negative sentiment among investors towards these stocks [2][3] Net Inflow Ratio Summary - The companies with the highest net inflow ratios are Shenzhen Expressway (深圳高速公路股份) at 68.48%, Anhui Wanshan Expressway (安徽皖通高速公路) at 64.22%, and Legend Holdings (联想控股) at 59.98% [1][3] - These ratios suggest a strong demand for shares in these companies relative to their trading volume [3] Net Outflow Ratio Summary - The companies with the highest net outflow ratios are Huadian International Power (华电国际电力股份) at -62.31%, CIMC Enric (中集安瑞科) at -54.98%, and Connoisseur-B (康诺亚-B) at -52.78% [1][3] - These figures indicate significant selling pressure and a lack of confidence among investors in these stocks [3]
联邦制药(3933.HK):BD首付贡献业绩 期待传统业务回暖
Ge Long Hui· 2025-10-30 19:55
Core Viewpoint - The company reported its H1 2025 performance, showing a revenue of 7.52 billion yuan (+4.8% YoY), EBITDA of 2.75 billion yuan (+23.3%), and net profit attributable to shareholders of 1.89 billion yuan (+27.0%) [1] Revenue Breakdown - The intermediate products business generated external revenue of 1.01 billion yuan (-23.1%) with a segment profit of 630 million yuan, resulting in a profit margin of 27.5% (-7.2 percentage points) [1] - The active pharmaceutical ingredients (APIs) segment reported external revenue of 2.53 billion yuan (-27.0%) and a segment profit of 250 million yuan, maintaining a profit margin of 27.5% (-4.9 percentage points) [1] - The formulation segment achieved external revenue of 2.54 billion yuan (+6.1%) with a segment profit of 160 million yuan, leading to a profit margin of 6.1% (-4.0 percentage points) [1] - Licensing revenue amounted to 1.43 billion yuan, primarily from the UBT251 licensing fee from Novo Nordisk [1] Business Performance - In the formulation business, human antibiotic product revenue was 890 million yuan (-12.1%), mainly impacted by centralized procurement and demand decline [2] - The animal health business generated revenue of 560 million yuan (-15.9%), with potential for rapid growth due to new base construction and overseas registration [2] - Insulin formulation revenue reached 960 million yuan (+74.5%), with second-generation insulin contributing 460 million yuan (+110.2%), and glargine insulin at 290 million yuan (+33.7%) [2] - The sales volume of insulin analogs increased by 90.4%, benefiting from the renewal of centralized procurement and orders from the Brazilian Ministry of Health [2] R&D Focus and Pipeline - The company is focusing its R&D on endocrine/metabolic and autoimmune fields, expecting to enter a harvest period starting in 2026 [3] - R&D investment in H1 2025 was 550 million yuan (+14.9%), with the domestic approval of liraglutide in March [3] - The new drug UBT251 targeting GLP-1/GIP/GCG has been licensed to Novo Nordisk, with ongoing clinical trials for weight loss and glycemic control [3] - The neuropeptide Y2 receptor agonist UBT37034 received clinical approval in the U.S. for weight loss indications, showing significant effects in animal trials [3] - The small molecule GLP-1 drug UBT48128 is expected to submit IND applications in mid-2026, with preclinical data indicating better weight loss effects than Eli Lilly's Orforglipron [3] - The company has a rich pipeline, anticipating six new products or indications to be approved in 2026 and 2027, with further approvals expected post-2030 [3] Investment Recommendation - The company is recognized as a leading comprehensive pharmaceutical enterprise, extending its business into biopharmaceuticals and animal health, with an R&D layout entering a harvest phase [3] - Projected revenues for 2025, 2026, and 2027 are 13.42 billion yuan, 12.65 billion yuan, and 13.84 billion yuan, reflecting YoY growth rates of -2.5%, -5.7%, and +9.4% respectively [3] - Expected net profits attributable to shareholders for the same years are 2.36 billion yuan, 2.02 billion yuan, and 2.41 billion yuan, with YoY growth rates of -11.4%, -14.2%, and +19.4% respectively [3] - Corresponding PE ratios (using an exchange rate of 1 HKD = 0.92 RMB) are projected at 10, 12, and 10 times, with an initial coverage rating of "Buy" [3]